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FDA 510(k)

VAPORTEMP HEAT AND MOISTURE EXCHANGER

K-Number: K922946 · 1993-03-08

ApplicantMallinckrodt Medical
Decision Date1993-03-08
Product CodeBYD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VAPORTEMP HEAT AND MOISTURE EXCHANGER is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Medical. It received FDA 510(k) clearance on 1993-03-08 under 510(k) number K922946. The device is classified under product code BYD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VAPORTEMP HEAT AND MOISTURE EXCHANGER?

VAPORTEMP HEAT AND MOISTURE EXCHANGER is a medical device that received FDA 510(k) clearance on 1993-03-08. The listed applicant is Mallinckrodt Medical. The 510(k) number is K922946.

When did VAPORTEMP HEAT AND MOISTURE EXCHANGER receive FDA 510(k) clearance?

VAPORTEMP HEAT AND MOISTURE EXCHANGER received FDA 510(k) clearance on 1993-03-08, under 510(k) number K922946.

Who is the listed applicant for VAPORTEMP HEAT AND MOISTURE EXCHANGER?

The FDA 510(k) record lists Mallinckrodt Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VAPORTEMP HEAT AND MOISTURE EXCHANGER?

The FDA product code for VAPORTEMP HEAT AND MOISTURE EXCHANGER is BYD.

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Other records listing Mallinckrodt Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K082520SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBESK051416SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULAK972258HI-CARE CLOSED SUCTION SYSTEMK971267SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUFK963732PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULAK955721CUFFED OROPHARYNGEAL AIRWAY (COPA)

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Related Devices (Code: BYD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K955008HEAT & MOISTURE EXCHANGERIntertech Resources, Inc.K954194DISPOSABLE HME/FILTEREngstrom MedicalK953580HEAT MOISTURE EXCHANGERIntertech Resources, Inc.K953507TYPE 1 & 2 (HUMIDAIR I & II)Icor ABK953544HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHTGibeck, Inc.K953620WARM N WET HMEF W/LUER ADAPTERHospitak, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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